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    FDA Orders Stronger Warnings for TNF-Blocker Drugs

    By Jennifer Huddleston, staff writer     

    The U.S. Food and Drug Administration (FDA) announced Sept. 4, 2008, that manufacturers of four tumor necrosis factor alpha blockers (TNF-alpha blockers)—Cimzia, Enbrel, Humira and Remicade—must strengthen their existing warnings, specifically highlighting the risk of fungal infections. [1]

    ”FDA has asked the manufacturers of these four drug products to highlight existing warnings of fungal infections,” said Jeffrey Siegel, a clinical team leader in the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products. “The box warning, which is the most serious warning in the labeling, must be upgraded to strongly warn doctors to consider the occurrence of histoplasmosis and other fungal infections.”
    [2]

    According to the Mayo Clinic Web site, TNF is a cell protein (cytokine) that causes inflammation. By blocking this inflammatory agent, TNF blockers can help reduce pain, stiffness and swelling.

    The four TNF-blocking drugs are approved to treat an assortment of conditions, including rheumatoid arthritis, Crohn’s disease, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.
    [3]

    While the TNF blockers, which suppress the immune system, carry warnings about the risk of serious infections, the FDA has found that healthcare professionals are failing to consistently recognize cases of invasive fungal infections, causing treatment delays that can lead to death.
    [4]

    The FDA reviewed 240 reports of histoplasmosis, an infection caused by the fungus Histoplasma casulatum. Histoplasmosis was initially unrecognized by healthcare professionals and treatment was delayed, causing the death of twelve patients.
    [5] While the histoplasmosis patients ranged from 8 to 86 years of age, no children died. [6]

    The FDA also received reports of coccidiodomycosis and blastomycosis in patients being treated with TNF blockers, including some deaths. [7] According to Siegel, a total of 45 patients died. [8]

    Under the FDA requirements, the manufacturers of the TNF blockers are obligated to submit changes to the safety warning labels within 30 days or provide reasoning why they feel the changes are unnecessary. If no new language is submitted or if the FDA disagrees with the manufacturers’ proposed changes, the FDA Amendments Act of 2007 allows the agency to order a label change the FDA deems appropriate.
    [9]

    The FDA warns that patients being treated with TNF blockers should be aware of an increased susceptibility to serious fungal infections and urges any patients who develop a persistent cough, fever, shortness of breath and fatigue to seek immediate medical attention.
    [10]


    [1] “FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections.” FDA Press Release. FDA.gov. Sept. 4, 2008.
    [2] Gardner, Amanda. “FDA Demands Tougher Warnings on Immunosuppressive Drugs.” U.S. News & World Report. Sept. 4, 2008.
    [3] “FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections.” FDA Press Release. FDA.gov. Sept. 4, 2008.
    [4]  Ibid.
    [5]  Ibid.
    [6] Hitti, Miranda. “Deaths Heighten Arthritis Drug Warning.” WebMD. Sept. 4, 2008.
    [7] “FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections.” FDA Press Release. FDA.gov. Sept. 4, 2008.
    [8] Heavey, Susan. “FDA Urges More Caution over TNF Blocker Infections.” Reuters. Sept. 4, 2008.
    [9] “FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections.” FDA Press Release. FDA.gov. Sept. 4, 2008.
    [10]  Ibid. 


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